Cleared Traditional

MAXI-FLOW SUCTION SET 12 FT.

K910170 · Adler Instrument Co. · General Hospital
Feb 1991
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K910170 is an FDA 510(k) clearance for the MAXI-FLOW SUCTION SET 12 FT., a Tubing, Noninvasive (Class II — Special Controls, product code GAZ), submitted by Adler Instrument Co. (Norcross, US). The FDA issued a Cleared decision on February 1, 1991, 17 days after receiving the submission on January 15, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K910170 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 1991
Decision Date February 01, 1991
Days to Decision 17 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code GAZ — Tubing, Noninvasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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